Analysis of a New Mask for Positive Airway Pressure (PAP) Device Users

Obstructive Sleep Apnea Clinical Trial

Official title:

Analysis of a New CPAP Mask for Patients With Sleep-disordered Breathing and Treated With Positive Airway Pressure (PAP) Thearapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01847846
• Other study ID #: MA07052013
• Secondary ID: MA07052013
• Status: Completed
• Phase: N/A
• Start date: July 2014
• Est. completion date: October 2014

Study information

• Verified date: February 2021
• Source: ResMed
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

BACKGROUND AND AIMS Continuous positive airway pressure (CPAP) is an effective therapy to treat sleep apnea. Sleep apnea is a condition where the airways collapse when the patient is asleep. CPAP treats sleep apnea by delivering an air pressure to the airways, splinting the airways open. CPAP is a device that sits besides the bed and is applied to the patient using a face mask.

The development of new CPAP masks is an on-going focus at ResMed Ltd in a bid to improve comfort and user compliance. ResMed are developing a new mask and investigations are required to evaluate mask performance over time.

ResMed Ltd design and manufacturer CPAP masks. The revision and development of masks is an on-going focus of the company in a bid to improve usability and patient compliance while maintaining optimum treatment. ResMed is developing a new mask. Investigations are therefore required to determine how much matter is built-up on the mask over time and to evaluate mask performance (including comfort and seal) and efficacy.

AIMS

The aims of the study are:

1. To measure and compare the change in the abundance of microbes on the new mask over a period of 8 weeks

2. To measure and compare the change in comfort, seal, stability, efficacy, leak and user compliance of this new mask over a period of 8 weeks

3. To measure and compare the change in comfort, seal, stability, efficacy, leak and user compliance of this new mask versus an available mask

It is hypothesised that:

1. The new mask acquires microbes from the user but there is no difference in the abundance of microorganisms between 2 and 8 weeks.

2. The new mask maintains the same degree of comfort, seal, stability, efficacy, leak and compliance between 2 and 8 weeks.

3. Compared to the existing mask, the new mask provides a higher degree of comfort, seal and stability and improves user compliance. The new mask also maintains efficacy, and maintains or reduces leak compared to the current masks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• At least 18 yrs old

• Diagnosed with obstructive sleep apnoea

• Been using CPAP therapy for at least 6 months

Exclusion Criteria:

• Has a lung disease/condition

• Using bilevel therapy

• Is unable to participate for the duration of the study

Related Conditions & MeSH terms

• Obstructive Sleep Apnea
• Sleep Apnea, Obstructive

Intervention

Device:
• CPAP mask - prototype
prototype mask, wore for all sleeps for 4 and 8 weeks (as randomly selected). Mask to be used in conjunction with participant's usual prescribed CPAP settings.

Locations

Country	Name	City	State
Australia	ResMed Ltd	Bella Vista	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
ResMed

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Measure and compare mask performance over a period of 8 weeks	Mask performance will be subjectively assessed by the user over a period of 8 weeks.; Varibles which will be measured are: Comfort; Mask seal; Mask stability; The occurence of red marks	after 2, 4, 6 and 8 weeks of use
Primary	To measure and compare the prevalence of microorganisms within the new mask over a period of 8 weeks	The mask is for single user use only. The participants will be instructed not to wash or clean the material for the duration of the study. The mask will be returned in a sealed bag and sent off for testing within 24 hrs after the trial.	up to 8 weeks of use
Secondary	Measure and compare mask efficacy over a period of 8 weeks	The efficacy variables that will be measured and compared at each time point are: Apnea Hypopnea Index (AHI; the number of apneas and hypopneas per hour), mask leak, number of hours of use per night, and user compliance will be measured	After 2, 4, 6 and 8 weeks of use